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OASIS Release 1.0

by Segami Corporation United States EUDAMED510(k)

510(k) K071584

Product code LLZ

Overview

OASIS Release 1.0 is a Nucleus Injection Device designed for the administration of contrast agents into intervertebral discs during discography procedures. It facilitates the injection of contrast media to assess disc integrity and diagnose spinal pathologies, particularly in the lumbar or cervical spine.

The device is supplied as a single-use, sterile instrument and is intended for use in clinical settings such as radiology departments. It is classified under product code LLZ and has received FDA 510(k) clearance and MDD compliance, ensuring adherence to regulatory standards. Storage and handling follow standard aseptic protocols for single-use medical devices.

Summary written by AI from registry data, 18 Sep 2026.Not verified

About this summary

This description and any FAQs on this page were generated automatically and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK071584 Date31 Aug 2007ClearedStatusActive
European UnionCE/MDD EUDAMED Number— Date—StatusActive

Coverage

2 jurisdictions

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring (legacy directive)
  • Not covered
  • European Union CE/MDD Expiring (legacy directive)
  • United States FDA 510(k) Active

Recalls: none on record (FDA, checked 22 Oct 2026)

Certificates: none listed in EUDAMED

Specification

EUDAMED · 510(k) · synced 22 Oct 2026

510(k) Number
FDA Product Code
LLZ
Device Class
Class II
Regulation
21 CFR Part 892.2050
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

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Questions

  • What is the OASIS Release 1.0 device specifically used for in a clinical setting?

    The OASIS Release 1.0 is designed for discography procedures, where it injects contrast agents into intervertebral discs to evaluate disc integrity and help diagnose spinal pathologies—particularly in the lumbar or cervical spine. This aids radiologists in assessing disc health during imaging studies.

  • Is the OASIS Release 1.0 device intended for single-use or repeated use?

    The device is explicitly labeled as single-use only, meaning it is not meant for reuse after a single procedure. This aligns with standard aseptic protocols for sterile medical instruments, ensuring patient safety and infection control.

  • How should the OASIS Release 1.0 device be stored to maintain its sterility?

    Since it is a sterile, single-use instrument, storage must follow standard aseptic protocols for medical devices. This typically includes keeping it in its original, unopened packaging in a clean, dry environment away from direct sunlight or extreme temperatures until ready for use.

  • What regulatory pathways has the OASIS Release 1.0 device undergone?

    The device has received FDA 510(k) clearance under product code LLZ and complies with the MDD (Medical Device Directive). It was determined *substantially equivalent* to a predicate device and reviewed by the Radiology (RA) Advisory Committee before clearance.

Properties & raw data

Show properties, registry sources and raw records

Sources (2)

  • FDA 510(k) K071584 24 fields · synced 22 Oct 2026
  • EUDAMED 1 fields · synced 19 May 2026